The following data is part of a premarket notification filed by Earlens Corporation with the FDA for Earlens Contact Hearing Aid.
| Device ID | K182480 |
| 510k Number | K182480 |
| Device Name: | Earlens Contact Hearing Aid |
| Classification | Tympanic Membrane Direct Contact Hearing Aid |
| Applicant | Earlens Corporation 4045 Campbell Avenue Menlo Park, CA 94025 |
| Contact | Judith A. Brimacombe |
| Correspondent | Judith A. Brimacombe Earlens Corporation 4045 Campbell Avenue Menlo Park, CA 94025 |
| Product Code | PLK |
| CFR Regulation Number | 874.3315 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-10 |
| Decision Date | 2019-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08500130070291 | K182480 | 000 |
| 00850013007233 | K182480 | 000 |
| 00850013007226 | K182480 | 000 |
| 00850013007219 | K182480 | 000 |
| 00850013007202 | K182480 | 000 |
| 00850013007417 | K182480 | 000 |
| 00850013007462 | K182480 | 000 |
| 00850013007578 | K182480 | 000 |
| 00850013007561 | K182480 | 000 |
| 00850013007554 | K182480 | 000 |
| 00850013007547 | K182480 | 000 |
| 00850013007530 | K182480 | 000 |
| 00850013007523 | K182480 | 000 |
| 00850013007240 | K182480 | 000 |
| 00850013007257 | K182480 | 000 |
| 00850013007264 | K182480 | 000 |
| 08500130070284 | K182480 | 000 |
| 08500130070277 | K182480 | 000 |
| 08500130070260 | K182480 | 000 |
| 08500130070253 | K182480 | 000 |
| 08500130070246 | K182480 | 000 |
| 08500130070239 | K182480 | 000 |
| 08500130070222 | K182480 | 000 |
| 08500130070215 | K182480 | 000 |
| 08500130070208 | K182480 | 000 |
| 00850013007295 | K182480 | 000 |
| 00850013007288 | K182480 | 000 |
| 00850013007271 | K182480 | 000 |
| 00850013007516 | K182480 | 000 |